Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting

Overview

Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.

Full Title of Study: “Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

Interventions

  • Device: Moyo strap-on
    • Continous measurements
  • Device: Hand-held fetoscope
    • Intermittent measurements

Arms, Groups and Cohorts

  • Experimental: Moyo strap-on
    • Continous fetal heart rate monitoring
  • Active Comparator: Hand-held fetoscope
    • Intermittent fetal heart rate monitoring

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of abnormal fetal heart rate detection
    • Time Frame: Up to delivery

Secondary Measures

  • Mode of delivery: vaginal versus operative
    • Time Frame: Up to delivery
  • Neonatal outcome: dead versus alive
    • Time Frame: Up to 24 hours
  • Time from abnormal fetal heart rate detection to delivery in minutes
    • Time Frame: Up to delivery

Participating in This Clinical Trial

Inclusion Criteria

  • Women admitted in labor

Exclusion Criteria

  • Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helse Stavanger HF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hege L. Ersdal, Md PhD, Study Director, Stavanger University Hospital, Norway

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